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Pitolisant
Venkatasai is a leading provider of pharmaceutical reference standards, specializing in the supply of high-purity Pitolisant reference materials. Our portfolio includes both pharmacopeial and non-pharmacopeial impurities, metabolites, stable isotope-labeled compounds, and nitrosamine derivatives (N-NO products). These reference standards play a crucial role in pharmaceutical R&D, aiding in formulation development, ANDA/DMF submissions, quality control, method validation, stability studies, and impurity profiling—including the identification and assessment of potentially genotoxic impurities.
Each Pitolisant-related product is rigorously characterized and delivered with a detailed Certificate of Analysis (COA) and comprehensive analytical data to ensure regulatory compliance. Upon request, we also offer EP/USP traceable standards. To maintain the highest quality standards, all materials are subject to periodic re-testing and continuous quality monitoring.
Pitolisant D6
Pitolisant Hydrochloride
Pitolisant Impurity 1
Pitolisant Impurity 2
Pitolisant Impurity 3
Pitolisant
Pitolisant N-oxide
Pitolisant Impurity 5
Pitolisant Impurity 6
Pitolisant Impurity 7 (PTL Deschloro impurity 01/22)
Pitolisant Impurity 8 (PTL1)
Pitolisant Impurity 9 (PTL1-PRD DIMER)
Pitolisant Impurity 10 (PTL/PTL3-PRD impurity 01/22)
Pitolisant Impurity 11 (PTL/PTL2(i))
Pitolisant Impurity 12 (PTL/PTL1 dimer01/22)
3-(4-chlorophenyl)propyl methanesulfonate (PTL2 GTI impurity)
1-(3-Butoxypropyl) Piperidine (PTL1 Butyl Impurity)
